| CTRI Number |
CTRI/2024/04/066292 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
14/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Oral Docosahexaenoic acid supplementation in Retinopathy of Prematurity in preterm |
|
Scientific Title of Study
|
A Study on assessing the effect of enteral Docosahexaenoic acid in Retinopathy of prematurity :An open labelled randomised controlled trail |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Cherukula sahithi |
| Designation |
M.D. Paediatrics |
| Affiliation |
INDIRA GANDHI INSTITUTE OF CHILD HEALTH |
| Address |
First floor NICU Indira Gandhi Institute of Child Health First block siddapura Jayanagar Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9505742023 |
| Fax |
|
| Email |
sahithisahi409@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Niranjan H S |
| Designation |
M.D. Paediatrics |
| Affiliation |
Indira Gandhi Institute of Child Health |
| Address |
First floor NICU Indira Gandhi Institute of Child Health First block Siddapura Jayanagar Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9505742023 |
| Fax |
|
| Email |
brniranjan_hs@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Cherukula sahithi |
| Designation |
M.D. Paediatrics Junior Resident |
| Affiliation |
Indira Gandhi Institute of Child Health |
| Address |
First floor NICU Indira Gandhi Institute of Child Health First block Siddapura Jayanagar Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9505742023 |
| Fax |
|
| Email |
sahithisahi409@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Cherukula Sahithi , md-pediatric student. First floor NICU Indira Gandhi Institute of Child Health First block Siddapura Jayanagar Bengaluru 560041 |
|
|
Primary Sponsor
|
| Name |
Cherukula Sahithi |
| Address |
Paediatric Medicine PG Student ,Thesis student in Department of Neonatology, NICU 1st floor Indira Gandhi Institute of Child Health, 1st block siddapura Jayanagar Bengaluru |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Cherukula sahithi |
Indira Gandhi Institute of Child Health |
Pediatric medicine pg student,Thesis student in Department of Neonatology,NICU 1st floor,Indira Gandhi Institute of Child Health 1st block Siddapura Jayanagar Bengaluru
Bangalore
KARNATAKA |
9505742023
sahithisahi409@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee igich bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H578||Other specified disorders of eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Enteral Docosahexaenoic supplementation |
Enteral supplementation Docosahexaenoic acid at 7mg/kg for a period of 4weeks |
| Intervention |
Enteral Docosahexaenoic supplementation |
Enteral supplementation of Docosahexaenoic Acid at 7mg/kg for a period of4weeks |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
7.00 Day(s) |
| Gender |
Both |
| Details |
Neonates with gestational age less than 34 weeks
Birth weight less than 2000 grams
Age less than 7 days
Initiated on enteral feeds
Informed and return concern of the parents/guardian
|
|
| ExclusionCriteria |
| Details |
Neonates with major congenital malformations
Neonates whose mother is on omega 3 supplements
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion of neonates with any stage of Retinopathy of prematurity according to International classification of Retinopathy of prematurity (ICROP) Criteria
|
4 weeks after administration of Docosahexaenoic acid |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
secondary outcome
1.Proportion of neonates with Stage 3 Retinopathy of prematurity
2.Proportion of Bronchopulmonary dysplasia
3.Proportion of Intraventricular hemorrhage more than or equal to grade 2
4.Proportion of Necrotising enterocolitis more than or equal to grade 2
5.Proportion of Extra Uterine Growth Retardation
6.Duration of hospital
7.Mortality |
4weeks after administration of Docosahexaenoic acid |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Retinopathy of prematurity (ROP) is a highly prevalent disease in premature neonates and is a leading preventable cause of childhood blindness¹.Extremely preterm birth cuts off the supply of the omega 6 long chain polyunsaturated fatty acid (LC-PUFAs) arachidonic acid and the omega 3 polyunsaturated fatty acids (LC-PUFAs) docosahexaenoic acid (DHA) which exerts pro angiogenic effects in increasing retinal vascularization.Thus the shortage of these LCPUFAs is associated with ROP progression. An Open labelled Randomized Controlled Trial conducted on neonates with gestational age <34weeks/<2kg with age <7days of life after randomization into DHA group or control group.Neonates randomized to DHA group will receive daily dose of 75mg/kg DHA for a period of 4 weeks and Neonates in Control group will not receive any supplementation and will be managed as standard NICU protocol.ROP screening will be done from 2nd week of life till 44 weeks of PMA and looks for development of any stage of ROP.
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